It is compulsory to use the Clinical Trials Information System (CTIS) when filing any new applications for clinical trials from 31 January 2023. The CTIS is a website designed for the implementation of Regulation 536/2014 on clinical trials. Although the regulation was adopted almost ten years ago, there is still uncertainty surrounding the implementation of the regulation’s requirements concerning greater transparency of clinical trials and, in particular, the scope of information to be published in the CTIS.
This is because, in general, the CTIS, which is publicly accessible, must contain all relevant details relating to clinical trials; this information may only be kept secret for the purpose of personal data protection and legitimate economic interests of sponsors (point 67 of the recitals in the regulation). Apart from specifying data that in general should not be considered commercially confidential, the regulation itself does not lay down detailed rules for identifying the data that is commercially confidential and places this within the remit of the EMA (art. 40(1) of the regulation).
After more than one year of public consultations concerning the draft of the document, on 10 July 2023, the European Medicines Agency (EMA) published the Guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS) Version 1.1. The guidance document lays down precise rules on what commercially confidential information can be redacted and how to use the deferral mechanism. There are major restrictions on the redaction of documents, and appropriate grounds must always be stated for the need to protect certain information. If the member state concerned permits deferral, this will delay the publication of certain documents, such as the protocol, investigator brochure, and informed consent information sheet, by a specified number of months or years (depending on factors such as the type of document and stage of the trial) subsequent to the conclusion of the trial in the EU/EEA or until the final summary of results is published. If the information placed in the CTIS has not been redacted, and publication has not been deferred, as a rule it is made public at the time the decision on the application to conduct a clinical trial is made.
Use of the CTIS will have a major impact on firms that sponsor clinical trials in the EU, as for the first time the general public – and competitors as well – will have access to an unprecedented amount of information concerning the production and testing of medical products. This also means that the EMA guidance will be a crucial tool for sponsors, while it remains to be seen whether the guidance will be interpreted – and consequently put into practice by individual member states – in a uniform manner throughout the EU.